At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Single-center, Randomized, Double-blind, Placebo-controlled, Ascending-Dose Study to Evaluate the Safety and Pharmacokinetics of Recombinant Human Plasma Gelsolin (Rhu-pGSN) After Intravenous Administration to Healthy Volunteers
In Brief
A Phase 1 clinical trial evaluating Recombinant human plasma gelsolin and placebo for Volunteers and Healthy. Completed, enrolled 32 participants across 1 site.
Detailed Summary
Study BTI-101 is a Phase 1, randomized, double-blind, placebo-controlled, dose escalation, parallel design study to evaluate the safety, tolerability, and pharmacokinetics of IV rhu-pGSN or saline placebo administered as 5 doses each of 6, 12, 18, or 24 mg/kg of body weight. Each of 4 dosing cohorts will include 8 subjects randomized 3:1 rhu-pGSN:placebo (6 rhu-pGSN subjects:2 placebo subjects). Subjects will be healthy adult volunteers 18-55 years of age.
Study Details
Timeline
Interventions
intravenous administration of either 6, 12, 18, or 24 mg/kg at time 0, 12, 36, 60 and 84 hours
intravenous administration of saline control at time 0, 12, 36, 60 and 84 hours